BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3007111389-2017-00012

    MDR report key: 6294624 · Received February 1, 2017

    Report

    Report Number
    3007111389-2017-00012
    Event Type
    Malfunction
    Date Received
    February 1, 2017
    Date of Event
    December 9, 2016
    Report Date
    February 1, 2017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS IPTH RESULTS WERE OBTAINED FOR AN API PROFICIENCY STUDY SAMPLE AND A NON-VITROS QC FLUID USING VITROS IPTH REAGENT IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE FOR THE HIGHER THAN EXPECTED VITROS IPTH RESULTS FOR THESE SAMPLES IS UNEXPECTED IPTH REAGENT PERFORMANCE. ORTHO PRODUCT CORRECTION NOTICE CL2016-196 INFORMED CUSTOMERS THAT THE REFERENCE INTERVAL FOR VITROS IPTH IS NO LONGER SUPPORTED DUE TO THE IDENTIFICATION OF A POSITIVE BIAS OF APPROXIMATELY 40% FOR SAMPLES WITH INTACT PTH CONCENTRATIONS <100 PG/ML COMPARED TO AN ALTERNATIVE COMMERCIALLY AVAILABLE METHOD. THE ORIGIN OF THE OVERALL POSITIVE BIAS IS CURRENTLY NOT KNOWN. THE INVESTIGATION IS ONGOING. THE FDA NEW YORK DISTRICT OFFICE WAS NOTIFIED OF THIS ISSUE ON 13 OCTOBER 2016. REFER TO REPORT NUMBER 3007111389-10/13/2016-001-C. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS IPTH RESULTS WHEN TESTING AN API PROFICIENCY SAMPLE AND A NON-VITROS QC FLUID USING VITROS IPTH REAGENT IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. THE FOLLOWING RESULTS BREACHED VITROS IPTH POTENTIAL HEALTH AND SAFETY CRITERIA: API 4: 52.6 PG/ML VERSUS EXPECTED RESULT OF 35.6 PG/ML. QC LEVEL 2: 271.15 PG/ML VERSUS EXPECTED RESULT OF 208.00 PG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE CUSTOMER GAVE NO INDICATION THAT ANY PATIENT RESULTS HAD BEEN AFFECTED. HOWEVER THE INVESTIGATION COULD NOT CONCLUDE THAT PATIENT RESULTS WERE NOT AFFECTED, NOR WOULD NOT BE AFFECTED, SHOULD THE EVENTS RECUR UNDETECTED. THERE IS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENTS. THIS REPORT IS NUMBER ONE OF TWO MDR'S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Patients

    Seq Age Sex Outcome Treatment
    1